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Comprehensive evaluation of lisedexamfetamine dimesylate in tratment of binge eating disorder alone and in combination with topiramte in 18_55 year_old edults

Protocol summary

Study aim
Comprehensive evaluation of lisedexamfetamine dimesylate in treatment of binge eating disorder alone and in combination with  topiramte
Design
Two arm parallel group randomized clinical trial with Permuted block randomization method and blinded outcome assessment comprehensive study of the two group is done before and after intervention
Settings and conduct
In the present randomized clinical trial study, 93 patients were selected by convenience sampling method and were allocated to two groups of 48 (lisedexamfetamin dimesylate alone)and 45 (lisedexamfetamin dimesylat with topiramate) using the permuted block randomization method.The diagnosis was made by the second author who is a well experienced psychiatrist through a systematic interview and filling up the Gormally questionnaire participent selected within who reffered to medical clinics of the city shiraz.the patients get treated for 12week. Prior entering the study, the participants were given the necessary explanations regarding the research and informed consent was obtained from them. It should be noted ,blinding is not done in this study
Participants/Inclusion and exclusion criteria
Inclusion criteria : Participants aged 18-55 years old meeting the diagnostic criteria for BED according to DSM-5 Exclusion criteria : posing other major psychological disorders assessed by psychiatrics (depression ,anxiety,..) Posing physical disease (.thyroid function disease ,gastrointestinal or cardiovascular disease) known sensitivity to LDX or TPM.
Intervention groups
Lisedexamfetamine dimesylate alone group1 Lisedexamfetamine dimesylate with topiramate group 2
Main outcome variables
binge eating score .BMI.weight .cholestrol.lipid profile.liver anzymes

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230910059396N1
Registration date: 2023-11-04, 1402/08/13
Registration timing: registered_while_recruiting

Last update: 2023-11-04, 1402/08/13
Update count: 0
Registration date
2023-11-04, 1402/08/13
Registrant information
Name
Farnoosh Mokhtari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 4223 3201
Email address
farmokhtariii@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-16, 1402/06/25
Expected recruitment end date
2023-11-21, 1402/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comprehensive evaluation of lisedexamfetamine dimesylate in tratment of binge eating disorder alone and in combination with topiramte in 18_55 year_old edults
Public title
evaluation of lisedexamfetamine dimesylate in tratment of binge eating disorder alone and in combination with topiramte in edults
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Participants aged 18-55 years old meeting the diagnostic criteria for BED according to DSM-5
Exclusion criteria:
Posing other major psychiatric disorders assessed by psychiatris (anxiety ,depression,..) Posing physical disease like cardiovascular diseases, thyroid disturbances or gastrointestinal diseases known sensitivity to LDX or TPM.
Age
From 18 years old to 55 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
In the present randomized clinical trial study, 93 patients were selected by convenience sampling method and were allocated to two groups of 48(lisedexamfetamine dimesylate alone groupA) and 45 (lisedexamfetamine dimesylate in combination with topiramate groupB ) using the permuted block randomization method. This is a individual randomization which is done using random allocation software, and a permutation block design was used, where the groups are coded as A, B. Block randomization method with blocks of four is one of the most widely used methods. Therefore, first we call the groups A, B We consider 4 different permutations of these 2 letters The 4 permutations of the two letters A and B are: AABB, ABAB, ABBA, BBAA, BABA, BAAB Each of these is a block of size 4, which includes 2 test group people and 2 control people, we determine randomly by tossing a coin that A, B Which one is the experiment and which one is the control. For allocation concealmen ,the letter A (indicator of intervention group 1 and receiving LDX ) or B (indicator of intervention group 2 and receiving LDX and TPM) are mentioned in the patient's prescription and then the patient is referred for delivery of drugs.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics comittee of kazeroon azad university
Street address
Alley 15,khoramshahr st,kazeroon,iran
City
Kazeroon
Province
Fars
Postal code
7318853171
Approval date
2022-01-16, 1400/10/26
Ethics committee reference number
IR.IAU.KAU.REC.1400.177

Health conditions studied

1

Description of health condition studied
Binge eating disorder
ICD-10 code
F50-81
ICD-10 code description
Binge eating disorder

Primary outcomes

1

Description
Binge eating score
Timepoint
At first and 3months after
Method of measurement
Bing eating scale of gormally

Secondary outcomes

1

Description
Body mass index
Timepoint
First qnd 3months after treatment
Method of measurement
Meter and wieght

Intervention groups

1

Description
Intervention group: Patients received LDX (n=48) LDX (produced by tekaje pharmaceutical company) was titrated from 30 mg/day to a maximum of 50mg/day for 12weeks. Assessement is done at first and then twelve weeks after receiving the treatment
Category
Treatment - Drugs

2

Description
Intervention group: 45 patients in the second group received LDX (produced by Tekaje pharmaceutical company)as the same 30 mg/day to a maximum of 50mg/day plus TPM (produced by sobhan pharmaceutical company)with starting dose of 25 mg/day and if tolerated, followed by max dose of 150 mg/day every night for 12weeks.Assessement is done at first and then twelve weeks after receiving the treatment.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Medical clinics of Shiraz
Full name of responsible person
Mahsa taghavi
Street address
Psychiatric clinic of Dr Mahsa Taghavi,second floor, Ahoora building, Maaliabad St., Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
7187731139
Phone
+98 71 3634 1771
Email
Dr_mahsataghavi@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mohammad hossein marhematizadeh
Street address
Azad islamic university .shahid soleimani blv .kazeroon
City
Kazeroon
Province
Fars
Postal code
7319866451
Phone
+98 71 4223 0505
Email
Farmokhtariii@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
1
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mahsa taghavi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Psychiatric clinic of Dr Mahsa Taghavi,second floor, Ahoora building, Maaliabad St., Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
7187731139
Phone
+98 71 3634 1771
Email
Dr_mahsataghavi@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mahsa taghavi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Psychiatric clinic of Dr Mahsa Taghavi,second floor, Ahoora building, Maaliabad St., Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
7187731139
Phone
+98 71 3634 1771
Email
Dr_mahsataghavi@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mahsa taghavi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Psychiatric clinic of Dr Mahsa Taghavi,second floor, Ahoora building, Maaliabad St., Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
7187731139
Phone
+98 71 3634 1771
Email
Dr_mahsataghavi@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
According to Declaration of Helsinki with ethical code IR.IAU.KAU.REC.1400.177 due to principle of confidentiality
When the data will become available and for how long
Accessrability 6month after release
To whom data/document is available
Scientic and academic researchers
Under which criteria data/document could be used
according to Declaration of Helsinki with ethical code IR.IAU.KAU.REC.1400.177 and with respecting to priciple of confidentiality for scientic researchers,data usage is permitted
From where data/document is obtainable
1. Refer to or correspond with the research unit of Kazeroon Islamic Azad University of Kazeroon with postal code of 7319866451 2.or with following adress mail ,Dr_mahsataghavi@yahoo.com
What processes are involved for a request to access data/document
Requests will be reviewed by the research unit of Islamic Azad University and the scientific officer of the research within a maximum period of twenty days, and if the necessary conditions are met, the data file will be provided to the requesters.
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